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Clinical Chemistry 44: 1452-1458, 1998;
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Right arrow Lipids, Lipoproteins, and Cardiovascular Risk Factors
(Clinical Chemistry. 1998;44:1452-1458.)
© 1998 American Association for Clinical Chemistry, Inc.

Lipids and Lipoproteins

Assessment of interlaboratory performance in external proficiency testing programs with a direct HDL-cholesterol assay

Nader Rifai1, Thomas G. Cole2, Elizabeth Iannotti1, Terence Law1, Michael Macke2, Richard Miller3, Dennis Dowd3, and Donald A. Wiebe3,a

1 Department of Laboratory Medicine, Children's Hospital and Department of Pathology, Harvard Medical School, Boston, MA 02115.

2 Department of Medicine, Washington University, St. Louis, MO 63110.

3 Department of Pathology and Laboratory Medicine, University of Wisconsin, Madison, WI 53792-2472.
a Address correspondence to this author at: 600 Highland Avenue, Madison, WI 53792-2472. Fax 608-263-0910; e-mail da.wiebe{at}hosp.wisc.edu.

Direct assays for the determination of HDL-cholesterol (HDL-C) have recently become available. The methods are precise, require small sample volume, and appear to be less affected by increased triglycerides than traditional precipitation methods. In this study, we describe the inter- and intralaboratory variability of the Boehringer Mannheim Corporation direct HDL-C assay and its performance in external proficiency testing surveys. A comparison study among three laboratories, using different analyzers and 85 serum specimens, showed a correlation coefficient (r) of 0.99. The direct HDL-C assay also showed good agreement with the ultracentrifugation-dextran sulfate-Mg2+ method (r = 0.98) and the Cholesterol Reference Method Laboratory Network-Designated Comparison Method (a = 0.98x + 4.75 mg/L, r = 0.98). Total error at medical decision levels ranged from -0.8% to +11.1%. Furthermore, this assay performed adequately in the College of American Pathologists and the ALERT® surveys as well as the CDC Lipid Standardization Program and met all performance criteria of regulatory agencies.




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